Ozempic injection label revised

The current prescribing information for Ozempic (semaglutide) injection, revised in May 2026 and posted on DailyMed, lists three approved uses in adults with type 2 diabetes: improving blood sugar control alongside diet and exercise, reducing the risk of major cardiovascular events in people with established heart disease, and slowing kidney damage by reducing the risk of sustained decline in kidney function, end-stage kidney disease, and cardiovascular death in patients with chronic kidney disease.^[1] These three indications are not new changes announced this month — they reflect the label as it currently stands, built up over Ozempic's history since its initial U.S. approval in 2017.^[1]

The dosing schedule described in the label has not changed. Patients start at 0.25 mg once weekly for four weeks, then increase to 0.5 mg weekly. If more blood sugar control is needed, the dose can rise to 1 mg after at least four weeks at 0.5 mg, and then to 2 mg after at least four weeks at 1 mg.^[1] For the kidney-related indication specifically, the label calls for increasing to 1 mg weekly after at least four weeks at the 0.5 mg dose.^[1] The most recent documented change to the label was in October 2025, when the warnings and precautions section was updated to add language on severe gastrointestinal adverse reactions.^[1]

The label carries a boxed warning about thyroid C-cell tumors. In rodent studies, semaglutide caused these tumors, though it remains unknown whether Ozempic causes them in humans, and the drug is contraindicated in people with a personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia syndrome type 2.^[1] Other warnings cover acute pancreatitis, diabetic retinopathy complications observed in a clinical trial, hypoglycemia risk when combined with insulin or insulin secretagogues, acute kidney injury from volume depletion, severe gastrointestinal reactions, hypersensitivity reactions including anaphylaxis, gallbladder disease, and pulmonary aspiration risk during anesthesia or deep sedation.^[1] The most common side effects reported in at least 5% of patients are nausea, vomiting, diarrhea, abdominal pain, and constipation.^[1]

Why it matters for patients

For people with type 2 diabetes who also have heart disease or chronic kidney disease, the label spells out that Ozempic is approved specifically to address those additional risks, not just blood sugar levels.^[1] This means a prescriber may consider Ozempic for reasons beyond glucose control if a patient has established cardiovascular disease or chronic kidney disease alongside type 2 diabetes.^[1] The label's dosing detail for the kidney indication — reaching 1 mg weekly rather than escalating further — is a specific technical point that differs slightly from the top glycemic dose of 2 mg.^[1]

The boxed warning on thyroid tumors and the contraindication for people with a personal or family history of medullary thyroid carcinoma or MEN 2 remain central safety information that has not changed.^[1] The label also notes that Ozempic should be discontinued in women at least two months before a planned pregnancy, given how long the drug remains in the body.^[1] None of this is medical advice; it reflects only what the current FDA-reviewed label states.

What happens next

The label reviewed here was last revised in May 2026, with the most recent substantive addition — expanded language on severe gastrointestinal adverse reactions — dated October 2025.^[1] The sources reviewed do not indicate any pending changes to Ozempic's indications, dosing, or warnings beyond what is currently listed. Any future revisions would appear as updates to the DailyMed listing and the FDA-approved prescribing information.^[1]